A Phase 1 Dose Escalation Study of OMP-21M18 in Subjects With Solid Tumors

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase 1 open-label dose escalation study of OMP-21M18 in subjects with previously treated solid tumour for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OncoMed Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

1. Subjects must have a histologically confirmed malignancy that is metastatic or unresectable for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. In addition, subjects must have a tumor that is at least 2 x 2 cm and is radiographically apparent on CT or MRI.

2. Subjects must have received their last chemotherapy, biologic, or investigational therapy at least 4 weeks prior to enrollment, 6 weeks if the last regimen included BCNU or mitomycin C.

3. Age >21 years

4. ECOG performance status <2

5. Life expectancy of more than 3 months

6. Subjects must have normal organ and marrow function as defined below:

• Leukocytes >3000/mL

• Absolute neutrophil count >1000/mL

• Hemoglobin >9.0 g/dL

• Platelets >100,000/mL

• Total bilirubin <1.5 X institutional upper limit of normal (ULN)

• AST (SGOT) and ALT (SGPT) <2.5 X institutional ULN

• PT and PTT within institutional ULN

• Creatinine <1.5 X institutional ULN OR

• Creatinine clearance >60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal

7. Women of childbearing potential must have had a prior hysterectomy or have a negative serum pregnancy test and be using adequate contraception prior to study entry and must agree to use adequate contraception from study entry through at least 6 months after discontinuation of study drug. Men must also agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and from study entry through at least 6 months after discontinuation of study drug.

Exclusion Criteria:

1. Subjects receiving any other investigational agents

2. Subjects with known brain metastases, uncontrolled seizure disorder, or active neurologic disease

3. History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy

4. Significant intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

5. Pregnant women or nursing women

6. Subjects with known HIV infection

7. Known bleeding disorder or coagulopathy

8. Subjects receiving heparin, warfarin, or other similar anticoagulants. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.

9. Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease